1.1 本试验方法适用于各种形状的材料以及不一定无菌的材料。该试验方法适用于材料数量有限的情况。例如，可以将小装置或粉末放置在琼脂上，并检查是否存在细胞生长抑制区。 1.1.1 本试验方法不适用于不通过琼脂或琼脂糖扩散的浸出物。 1.1.2 虽然琼脂层可以起到缓冲作用，以保护细胞免受样本的伤害，但可能存在足够重的材料，以压缩琼脂并防止扩散或对细胞造成机械损伤。该试验方法不适用于这些材料。 1.2 选择L-929细胞系是因为它在这种类型的分析中有着重要的使用历史。 这并不意味着优选使用L-929，仅表明L-929是一种已建立的细胞系，具有良好的特征且易于获得，已在多个实验室中证明了可重复的结果。 1.3 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.4 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管限制的适用性。 ====意义和用途====== 4.1 该测试方法有助于评估新材料和配方的细胞毒性潜力，并作为既定医疗器械和组件质量控制计划的一部分。 4.2 本试验方法假设细胞毒性评估提供有用信息，有助于预测人类的潜在临床应用。细胞培养方法与动物试验显示出良好的相关性，并且通常对细胞毒性药物更敏感。 4.3 该细胞培养试验方法适用于将用于制造植入人体或长期接触组织液或血液的医疗器械的材料的规范和标准。 4.4 一些在医疗器械中具有安全临床使用历史的生物材料具有细胞毒性。该测试方法并不意味着所有生物材料必须通过该测试才能被视为安全用于临床（实践） F748 ).

1.1 This test method is appropriate for materials in a variety of shapes and for materials that are not necessarily sterile. This test method would be appropriate in situations in which the amount of material is limited. For example, small devices or powders could be placed on the agar and the presence of a zone of inhibition of cell growth could be examined. 1.1.1 This test method is not appropriate for leachables that do not diffuse through agar or agarose. 1.1.2 While the agar layer can act as a cushion to protect the cells from the specimen, there may be materials that are sufficiently heavy to compress the agar and prevent diffusion or to cause mechanical damage to the cells. This test method would not be appropriate for these materials. 1.2 The L-929 cell line was chosen because it has a significant history of use in assays of this type. This is not intended to imply that its use is preferred, only that the L-929 is an established cell line, well characterized and readily available, that has demonstrated reproducible results in several laboratories. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== 4.1 This test method is useful for assessing the cytotoxic potential of new materials and formulations and as part of a quality control program for established medical devices and components. 4.2 This test method assumes that assessment of cytotoxicity provides useful information to aid in predicting the potential clinical applications in humans. Cell culture methods have shown good correlation with animal assays and are frequently more sensitive to cytotoxic agents. 4.3 This cell culture test method is suitable for incorporation into specifications and standards for materials to be used in the construction of medical devices that are to be implanted into the human body or placed in contact with tissue fluids or blood on a long-term basis. 4.4 Some biomaterials with a history of safe clinical use in medical devices are cytotoxic. This test method does not imply that all biomaterials must pass this assay to be considered safe for clinical use (Practice F748 ).